Hemorrhage Risk Prescribed Arixtra

NCT01064362 | Completed Results

• 3 other identifiers: 113962EPI40612WEUSRTP4388
• Study Type: observational
• Target: 13,442
• Locations: 0 countries
• Sites: N/A

Brief Summary

Arixtra (fondaparinux sodium) was the first selective Factor Xa inhibitor to be marketed. As with all anticoagulants, an important adverse event associated with Arixtra use is haemorrhage. Previous studies using clinical trial and observational data show no difference in the risk of haemorrhage in patients treated with Arixtra compared to (low molecular weight heparins) LMWHs. This study will assess the risk of haemorrhage in major orthopaedic surgery patients (hip fracture surgery and/or hip/knee replacement surgery) treated with either Arixtra or LMWH for thromboprophylaxis and will provide additional observational data from a European country to strengthen the comprehensive review of haemorrhage and the post-marketing safety of Arixtra. All patients age 18 years and older with a primary discharge diagnosis for hip fracture surgery and/or a hospitalization for hip and/or knee replacement surgery from the PHARMO RLS database in the Netherlands are eligible for participation. For study inclusion patients must receive either Arixtra or LMWH as initial in-hospital thromboprophylactic agent and have at least three months in the PHARMO RLS database before cohort entry date. Patients with a history of hospitalization for haemorrhage, renal failure or liver failure in the past 3 months will be excluded. Descriptive statistics, including gender, age, length of treatment, co-morbidities, concomitant medications, and other covariates will be calculated. Data for this study were obtained from different registers in the PHARMO medical record linkage system (PHARMO RLS) in the Netherlands. The PHARMO medical record linkage system is a population-based patient-centric data tracking system that includes high quality and complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million community-dwelling inhabitants of 48 geo-demographic areas in the Netherlands. The PHARMO registers are linked on a patient level and contain unprecedented accurate and complete information required for the study. The out patient database contains drug dispensing data in the U-Expo database are encoded according to standards based upon the Z-Index drug database (www.z-index.nl). Therefore, it is possible to identify and classify drug use in time, both on the basis of national and international classification schemes as well as on the basis of individual active ingredients and administration forms. Of each dispensed drug, the Anatomical Therapeutic Chemical (ATC) code, the dispensing date, the prescriber, the prescribed dosage regimen, the dispensed quantity, the cost and the estimated legend duration of use are available. The hospital pharmacy database comprises hospital pharmacy data collected in a growing number of non-academic hospitals in the Netherlands. Currently, data are collected on patient level for more than one million patients from a representative sample of non-academic hospital pharmacies scattered over the Netherlands. The hospital pharmacy database includes data on in-patient medication orders such as type of drug, dose, and time of administration and duration of use. The Dutch Medical Register (LMR) is the data source comprising all hospital admissions in the Netherlands (www.prismant.nl). These records include detailed information concerning the primary and secondary discharge diagnoses, diagnostic, surgical and treatment procedures, type and frequency of consultations with medical specialists and dates of hospital admission and discharge. All diagnoses are coded according to the International Classification of Diseases, 9th edition (ICD-9-CM). Currently, data until December 2008 are available.

Conditions

Thrombosis, Venous

Keywords

Haemorrhage; Thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)

  Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.

  Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first

Secondary Outcomes (1)

• Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)

  Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first.

Study Arms (1)

Prophylaxis following major orthopedic surgery

Patients age 18 years and older in the PHARMO RLS database treated with either fondaparinux sodium or LMWH for thromboprophylaxis following hip fracture and/or hip/knee replacement surgery.

Drug: Fondaparinux sodium; Drug: Low molecular weight heparin (LMWH)

Interventions

Fondaparinux sodium DRUG

Fondaparinux sodium for thromboprophylaxis (ATC: B01AX05)

Prophylaxis following major orthopedic surgery

Low molecular weight heparin (LMWH) DRUG

LMWH including: dalteparin, nadroparin, enoxaparin or tinzaparin (ATC:B01AB (excluding B01AB01))

Prophylaxis following major orthopedic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients age 18 years and older with a primary discharge diagnosis of hip fracture surgery or hospitalization for hip replacement surgery or knee replacement surgery treated with either fondaparinux sodium or LMWH for thrombopropylaxis between January 2003 and September 2008

You may qualify if:

• Age 18 years and older; Treatment with either Arixtra or LMWH as initial in-hospital thromboprophylactic agent; At least three months history in the PHARMO RLS database before cohort entry date

You may not qualify if:

• Hospitalization for haemorrhage, renal failure or liver failure in the 3 months before cohort entry date

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Venous Thrombosis; Hemorrhage

Interventions

Fondaparinux; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates; Heparin; Glycosaminoglycans

Limitations and Caveats

Differences among hospitals in the registration of events (not all events were captured), the presence of policlinical pharmacy, and different drug usage patterns in each hospital did not enable a valid comparison of the risk of haemorrhage.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 8, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 12, 2015
• Results First Posted: February 11, 2011

Record last verified: 2011-06